COVID-19, SARS-CoV 2
Conditions
Keywords
COVID-19, Coronavirus, COVID, SARS-COV-2
Brief summary
Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.
Interventions
Bicalutamide 150 mg by mouth daily for 7 days
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * COVID-19 infection, confirmed by polymerase chain reaction (PCR) test \<=3 days from enrollment * Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms * Able to provide informed consent
Exclusion criteria
* Unable to take oral medication * Pregnant or breastfeeding * On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry * Requiring ≥6L oxygen or respiratory rate ≥30 * Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry * Known hypersensitivity to bicalutamide or its components. * A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin \> 3x the upper limit of normal * Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction \< 40% * Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who have clinical improvement at day 7 after randomization | up to 7 days | Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | up to 60 days | Number of calendar days in the hospital |
| Percentage of patients needing upgrade to the intermediate care unit (IMC) | up to 60 days | — |
| Duration of IMC stay | up to 60 days | Number of calendar days in IMC |
| Percentage of patients needing upgrade to the intensive care unit (ICU) | up to 60 days | — |
| All-cause mortality | 28 days | Number of participants deceased for any cause |
| Number of participants requiring mechanical ventilation | up to 60 days | — |
| Duration of mechanical ventilation | up to 60 days | Number of calendar days requiring mechanical ventilation |
| Number of participants experiencing adverse events | up to 60 days | Number of participants who are COVID-19 positive, experiencing adverse events as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Duration of ICU stay | up to 60 days | Number of calendar days in ICU |
Countries
United States
Outcome results
None listed